Ab­b­Vie preps an FDA pitch of promis­ing PhI­II da­ta for block­buster hope­ful elagolix

Ab­b­Vie is rolling out the Phase III da­ta it will de­liv­er to the FDA lat­er this year in search of a block­buster ap­proval for elagolix, a top late-stage prospect in their pipeline aimed at crip­pling bouts of en­dometrio­sis. And the in­ves­ti­ga­tors in the study have put some sol­id da­ta on dis­play at the 13th World Con­gress on En­dometrio­sis in Van­cou­ver this af­ter­noon.

In an ab­stract shared with End­points News ear­li­er in the week, Ab­b­Vie re­port­ed that the drug — an oral go­nadotropin-re­leas­ing hor­mone (GnRH) re­cep­tor an­tag­o­nist — demon­strat­ed some clear, dose-de­pen­dent re­spons­es that eas­i­ly out­paced the place­bo arms in two Phase III tri­als, each with more than 800 women en­rolled in them. Both stud­ies tracked clin­i­cal re­spons­es for dys­men­or­rhea — acute and po­ten­tial­ly dis­abling men­stru­al pain — as well as non­men­stru­al pelvic pain.

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